510(k) · Cleared
ClearedON the GO Sharps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medport, Inc. · MMK Container, Sharps
Cleared on Jul 13, 2007 as substantially equivalent to K041153 (Arrow Intl., Inc., 2004) after a 135-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Jul 13, 2007
- Review
- 135 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946289 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK946289 Devons Point Lok Needle Protection DeviceDevon Industries, Inc. · 1995
- 1 generation backK041153 Sharpsaway II Locking Disposable CupArrow Intl., Inc. · 2004
- This deviceK070577 ON the GO SharpsMedport, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK081821 D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081821D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946289 | Devons Point Lok Needle Protection Device | Devon Industries, Inc. | 1995 | — |
| −1 | K041153 | Sharpsaway II Locking Disposable Cup | Arrow Intl., Inc. | 2004 | — |
| 0 (this device) | K070577 | ON the GO Sharps | Medport, Inc. | 2007 | — |
| +1 | K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMK device
- #1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041153 | Sharpsaway II Locking Disposable CupSummary page 1…Providence, RI 02903 Correspondent: Fran WhitE MDC Associates, LLC 163 Cabot Street Beverly, MA 01915 Substantially Eqiuivalent Device: K041 153 Sharps AwayTm Locking Disposal Cup Product Description: On the Go Sharps Container is designed as a single use device that holds… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081821 (Global Pathogen Solutions, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMK
No recall names MMK since 2007.
Adverse event reports per year · MMK
5in 2025
MAUDE reports naming product code MMK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070577: ON the GO Sharps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070577
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026